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MS Trial Alert - Investigators Enrolling People in UK with MS in Study of Cannabis for Neuroprotection, and in Study of Cannabis for Muscle Stiffness

Submitted by admin on Wed, 04/02/2008 - 00:00

MS Trial Alert - Investigators Enrolling People in UK with MS in Study of Cannabis for Neuroprotection, and in Study of Cannabis for Muscle Stiffness

Summary:

Investigators in the United Kingdom, led by primary investigator John Zajicek, MD (Peninsula Medical School, Plymouth, UK) are recruiting people with MS for two studies using experimental cannabis (marijuana-derived) treatments. The CUPID study is evaluating the safety and effectiveness of using the cannabis derivative dronabinol to protect the nervous system from damage and slow down disease progression in 492 people with primary-progressive or secondary-progressive MS. The MUSEC study is evaluating the use of an oral cannabis extract for treating muscle stiffness in 400 people with all types of MS.

Rationale:

Some people with MS report that marijuana relieves several of their MS symptoms, such as spasticity and pain. However, scientific studies completed thus far have not generally provided convincing evidence that marijuana or its derivatives provide substantiated benefits for symptoms of MS. Unexpected findings from some studies as well as laboratory findings – also inconclusive – show that marijuana may even have neuroprotective (nerve tissue-protecting) effects. The current studies are designed to yield more insight into the potential benefits of cannabis and its derivatives for people with MS.

Eligibility and Details

CUPID:

In this study, people with primary- or secondary-progressive MS between the ages of 18 and 65 are being randomly assigned to receive oral dronabinol daily in two doses (328 people) or inactive placebo (164 people) for three years. The primary outcome being measured is the time to progression as determined by the EDSS scale of MS disease activity, as well as scores on the physical component of the MS Impact Scale. The UK Medical Research Council, MS Society of Great Britain and Northern Ireland, and UK MS Trust are sponsoring this study.

MUSEC:

In this study, 400 people with all types of MS, who have been stable for at least six months, are being randomly assigned to receive an oral cannabis extract or placebo for 12 weeks. The primary goal is to determine whether muscle stiffness improves using a numerical scale, and secondary outcomes are measuring effects on pain, spasms, sleep disturbance, walking ability and quality of life. This study is funded by Weleda AG and Institut fur Klinische Forschung, Germany.

Contact:

Please note that these studies are recruiting patients in the United Kingdom.

For more information on the CUPID study, contact Jane Vickrey, Trial Coordinator, atcupid@pms.ac.uk

For more information on the MUSEC study, contact Suzi Reilly at +44-1752-315 250, ext. 250, or visitwww.msmusecstudy.com